The National Medical Products Administration: Speed up the review and approval of urgently needed clinical products and include eligible products in the priority review and approval process.
Li Li, the director of the National Medical Products Administration, stated today at a press conference that they aim to improve the efficiency of the review and approval process.
Speed up the review and approval of urgently needed clinical products, include eligible products in the priority review and approval process, shorten the time limits for technical review, registration verification, and registration inspection, and accelerate the approval process.
Shorten the implied license time for clinical trials and pilot programs in Beijing, Shanghai, and other areas, reducing the review and approval time for innovative drug clinical trials from 60 working days to 30 working days.
Optimize the supplementary application review and approval process for drugs in eligible provinces, provide pre-registration verification and inspection services for post-marketing changes, and significantly reduce the review time for supplementary applications.
CICC releases research reports stating that due to the impact of the macro environment, the medical insurance fund payment is under pressure, and there is stricter fund supervision, with the overall domestic medical demand expected to be weak in the second half of the year. However, due to the aging trend, medical insurance fund expenditure and medical treatment demand are expected to continue to grow steadily in the long term. Benefiting from policy support, domestic sales of innovative drugs are expected to maintain strong growth. Expectations of overseas interest rate cuts may drive a rebound in the high-elasticity innovative drug sector valuation. Continues to be bullish on leading innovative drugs (including Pharma/Biotech), solid-performing and attractively valued consumer medical companies, and leading medical device companies.
Soochow Securities releases research reports stating that the development of domestic new drugs in various stages of clinical trials and participation in international multicenter clinical trials reflects a significant increase in China's research and development capabilities. Compared to the Chinese market, some developed countries overseas demonstrate higher market payment capability for innovative drugs, providing a broader pricing space, resulting in higher returns for the research and development of innovative drugs.
China's innovative drugs have multiple overseas expansion models, fully demonstrating their global competitiveness.
With the large-scale listing of high-potential domestic innovative drugs, Soochow Securities predicts that several pharmaceutical companies will achieve profitability in 2024-2026 through benchmarking their sales volume with those of overseas pharmaceutical giants.
Leading Hong Kong-listed companies in the innovative drug sector:
Akeso (09926), Innovent Bio (01801), Beigene (06160), Innocare (09969), Luye Pharma (02186), Fosun Pharma (02196), Sino Biopharm (01177), Remegen (09995), I-Mab (01542), Kangze Medical (00867), etc.